Invizius announces ‘Angry Blood’ Haemodialysis Study and recruits its 300th patient.

Novel study is investigating dysregulation of the complement system during standard hemodialysis therapy in relation to patient health outcomes.

Glasgow, Scotland, 13 June 2023 – Invizius Limited (“Invizius”), a biotechnology company developing second generation therapies for a range of complement-driven autoimmune and inflammatory disorders, is pleased to announce that it has recruited its 300^th patient to the ‘Angry Blood’ study. This is a significant milestone in its novel kinetic study to identify patients with elevated complement responses during haemodialysis (HD), so-called ‘angry blood,’ who may have a high risk of serious cardiovascular complications, the major cause of mortality in HD patients.

Angry blood occurs in ±20% of patients undergoing HD, making them more susceptible to heart disease, risk of stroke, damage to blood vessels and a very poor patient prognosis. During HD, blood interacts with the biomaterials of the HD circuit. This interaction activates the complement system, which plays a key role in the innate immune response but, when dysregulated, contributes to the development of numerous diseases.

The 525-patient study aims to assess ‘complement activation’ during HD in patients with end stage renal failure, and its link to the patient’s risk of serious complications during dialysis. Dialysis patients from collaborating centres across the Northwest, in the UK at the Royal Preston Hospital, Salford Royal NHS Foundation Trust and Liverpool Royal Infirmary, will be participating in the ongoing evaluation study. This will enable Invizius to stratify the patient population in preparation for the upcoming First-in-Human clinical study of H-Guard® Priming Solution.

Subject to approvals by the Medicines and Healthcare products Regulatory Agency (MHRA) and Ethics, the First-in-Human study of H-Guard will commence mid-year, 2023. The study will be led by Professor Sandip Mitra and Co-investigators Dr Duha Ilyas and Dr Leonard Ebah from the Manchester Royal Infirmary and is taking place at the Manchester University Hospitals NHS Foundation Trust (MFT).

H-Guard® Priming Solution is a highly potent second generation complement regulator which coats the dialysis filter and tubing during the priming process. This is designed to suppress complement activation on the extracorporeal circuit’s surfaces by recruiting and enhancing the patient’s own, natural complement modulator, Factor H, whilst still allowing effective infection control.

Richard Boyd, Chief Executive Officer of Invizius, said: “We are delighted with the progress of this unique, smart clinical study which will allow us to identify patients for our First-in-Human clinical study of H-Guard. H-Guard has the potential to address the serious complement-driven complications of haemodialysis. By stratifying patients and treating those most at risk, we can ensure H-Guard’s efficacy while reducing cost- and time-to-market.”

Dr Andy Herbert, Chief Technology Officer, commented: “We are only halfway through our ‘Angry Blood’ study but the kinetic data on complement and immune activation we are obtaining is providing valuable insights into the problems faced by a number of dialysis patients. Complement activation is one of the fastest and most powerful biological responses known and collecting kinetic samples at this scale has never been attempted before. Therefore, we are getting a unique insight into what is happening to patients with ‘Angry Blood’ and how H-Guard may operate in the clinic.”

The ‘Angry Blood” study name is CompAct-HD: “Investigating biomarkers of Complement Activation in patients during HaemoDialysis.”